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The transition of a drug candidate molecule from discovery to clinical investigation is an important moment in any development program. Central to this process are toxicology studies, which serve as the primary mechanism for generating safety profiles and establishing...

The transition of a drug candidate from discovery to clinical trial application is one of the most high-stakes phases in drug development. Acute toxicity studies are a foundational component of IND-enabling toxicology programs, providing the early safety data needed...

In the competitive landscape of drug development, speed to the clinic must be balanced with the highest standards of safety and regulatory compliance. For mid-sized and large manufacturers alike, the foundational data generated during the earliest phases of testing...

The trajectory of a pharmaceutical program often hinges on the quality of its early safety data. When considering “what is MTD in drug development?” it's essential to look beyond a simple numeric value and view it as a cornerstone of strategic decision-making. The...

The concept of Chimeric antigen receptor T cell (CAR-T) therapy was first proposed in the late 1980s, and CAR design has continuously evolved in both structure and function.  This form of therapy has already benefitted tens of thousands of cancer patients, and...

The success of GLP-1 drugs has driven a surge in advanced peptide therapeutic development and has transformed the treatment of metabolic disease. Engineered peptides can deliver long-acting, highly-specific therapies, but their popularity has reached such a peak that...

The European Union (EU) is the world’s second-largest pharmaceutical market and boasts abundant clinical resources for biopharmaceutical companies seeking global expansion. However, the region has a distinct regulatory architecture and high compliance costs,...

Drug metabolism and pharmacokinetics (DMPK) studies are a crucial step in identifying drugs with sufficient potential to advance through the development process. They help determine the pharmacokinetic characteristics of drug candidates through comprehensive...

Antibody-drug conjugates (ADCs) benefit from an elegant design. When functioning to their full potential, they entrust an antibody to guide a therapeutic payload directly to tumor cells, while avoiding unwanted effects on healthy tissue. This combination of...

Skin sensitization is defined as an allergic response triggered by a substance that induces an overreaction of the immune system, and it is a crucial concern for pharmaceutical and medical device developers. Rigorous testing for skin sensitization is an essential part...

Over the past decade, oligonucleotides have moved from a theoretical concept to a clinical mainstay, revolutionizing the rules of targeted therapy. By harnessing short, chemically synthesized strands of DNA or RNA, these molecules act as precision editors of gene...

Peptide therapeutics are among the most promising (and commercially successful) areas of drug development today Their high target specificity, favorable efficacy profiles, and manageable dosing regimens make them well suited for precision medicine approaches. Advances...